Senior Validation Engineer - CGT Data & Lab Systems
Smart IT Frame LLC
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Job summary
Smart IT Frame LLC in California is seeking a Validation Engineer to lead testing and validation of laboratory instrument integrations across Analytical Development and Quality Control. You will drive data pipelines and ensure ALCOA+ data integrity while supporting GxP release cycles and 21 CFR Part 11 compliance.
You will collaborate with cross-functional teams, write validation protocols, and manage defect lifecycles in a global delivery environment.
Qualifications
- Proven experience in lab informatics test projects in pharma/biotech environments.
- Hands-on data integration testing across APIs, data flows and schemas (JSON/XML).
- Strong knowledge of GxP, CSV, and validation of regulated software.
- Experience with test management and agile delivery (HP ALM, Jira).
- Awareness of test automation opportunities to reduce manual testing.
- Knowledge of pharmaceutical or CGT supply chain processes is a plus.
- Ability to develop and execute test plans and scripts for validated apps.
Responsibilities
- Lead testing of instrument-to-cloud integrations via CGTs platforms.
- Write and execute validation protocols (IQ/OQ/PQ equivalents for software).
- Ensure data integrity and ALCOA+ adherence across systems.
- Collaborate with analytics, engineering, and IT teams in a global setting.
- Manage defect lifecycles and communicate complex issues to stakeholders.
Skills
Tools
Job description
Smart IT Frame LLC in California is seeking a Validation Engineer to lead testing and validation of laboratory instrument integrations across Analytical Development and Quality Control. You will drive data pipelines and ensure ALCOA+ data integrity while supporting GxP release cycles and 21 CFR Part 11 compliance.
You will collaborate with cross-functional teams, write validation protocols, and manage defect lifecycles in a global delivery environment.
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